Addressing the bureaucracy challenge
EHA has recently brought key stakeholders around the table to discuss bureaucratic obstacles in clinical research. Regulators, patient organizations, the European Commission and industry representatives were invited for a day-long discussion at EHA offices, building on an informal dialogue with the European Medicines Agency (EMA) that had been initiated by a group of prominent clinical researchers.
The roundtable meeting addressed the issues faced by clinicians and patients as a consequence of the increasing administrative burden that comes with conducting clinical trials. Two of the initiators, Simon Rule and Steven Le Gouill, recently expressed their frustration in an article in the British Medical Journal, Bureaucracy is strangling clinical research. The authors point out that the exponential growth of administrative requirements increases the cost of clinical trials and decreases patient safety, as truly important signals are lost, diluted in an unmanageable number of trivial queries and unfiltered notifications of suspected unexpected serious adverse reactions (SUSARs), amongst other issues.
Next steps include the drafting of a high-level action plan, based on input from the roundtable participants, and involvement of other medical disciplines in the discussion, with an important role foreseen for the BioMed Alliance.